QC Associate II

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

This is a Wed - Sat AM shift (6a - 1:30p)

PURPOSE AND SCOPE OF POSITION:

The primary focus of the Quality Control Associate II role will be to support product lot release and in-process testing within a cGMP environment. Additionally, this role may provide limited technical support and troubleshooting for the support of lot release, in-process, and stability testing.

REQUIRED COMPETENCIES:? Knowledge, Skills, and Abilities:

Education:

BS in a scientific discipline.

Experience

3 years of analytical QC testing within a regulated environment, or equivalent combination of education and experience.

Experience working in a regulated (GxP) environment and familiarity with various Quality Systems, preferred.

Demonstrated success working in a high-performing, business results-driven environment.

Knowledge, Skills, and Abilities

Ability to work in a high paced team environment, meet deadlines, and prioritize work from multiple projects with little supervision.

Strong analytical and communication skills.

Computer proficiency as well as strong scientific and organizational skills.

Experience working in a GMP environment.

Demonstrated success working in a high-performing, business results-driven environment.

Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others.

Ability to maintain flexible intellect and adjust to a dynamic work environment.

DUTIES AND RESPONSIBILITIES:

Key Responsibilities

Perform or support cGMP lot release, in-process, and stability testing using various software packages.

Ensure timely completion of testing and tasks as assigned.

Perform assay and form review.

Support assay transfer and method validation of by executing cross-site validation protocols and providing data to support final reports.

Participate in cross-functional training.

Revise test methods, SOPs, raw material specification, and/or sample plans as appropriate.

Identify and facilitate continuous improvements.

Participate in technical transfer and validation protocols for QC assays.

Maintain instrumentation and equipment preventative maintenance and supporting documentation in a cGMP compliant manner.

Assist in the implementation of new assay methodologies and the associated instrumentation.

Onboard new materials and reagents.

Identify and support initiation and completion of Deviations, CAPAs and Laboratory Investigations.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.

This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management.

WORKING CONDITIONS (US Only):

While performing the duties of this job, the employee is frequently required to stand; walk; sit; bend; stretch; use hands and fingers, with various manipulations; reach with hands and arms; and effectively communicate with others in the workplace, including the ability to make and promptly respond to audible cues and warnings.

Work in areas that may have strong magnets.

May work in areas with exposure to vapor phase liquid nitrogen.

Must have ability to work assigned shift (Day, Night, Weekends and/or holidays).

Will be required to wear personal protective equipment (PPE) and other clean room garments daily. This may include, but not limited to: safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hairnets, gloves, and hearing protection.

Require to work in and around laboratories and controlled, enclosed, restricted areas, included clean rooms.

Require to carry and/or lift up to 10 pounds several times a day.

Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

Bristol-Myers Squibb Company
Website : http://www.bms.com